NCT05434377

Brief Summary

Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

June 21, 2022

Last Update Submit

February 6, 2024

Conditions

Vitamin D DeficiencyEnd Stage Renal Disease

Keywords

vitamin D insufficiencydialysisergocalciferol

Outcome Measures

Primary Outcomes (1)

  • proportion of patients with vitamin D adequacy

    serum 25(OH)D more than 30 ng/ml

    6 months

Secondary Outcomes (5)

  • serum calcium

    6 months

  • serum phosphorus

    6 months

  • serum intact parathyroid hormone

    6 months

  • muscle mass

    6 months

  • muscle strength

    6 months

Study Arms (2)

Vitamin D supplementation using titration regimen

ACTIVE COMPARATOR

Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described * serum 25(OH)D \< 5 ng/ml --\> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months * serum 25(OH)D 5-15 ng/ml--\> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months * serum 25(OH)D 16-30 ng/ml--\> receive ergocalciferol 50,000 IU monthly for 6 months

Other: ergocalciferol supplementationOther: dialysis techniquesOther: sunlight exposure time

Vitamin D supplementation using fixed dose regimen

EXPERIMENTAL

Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.

Other: ergocalciferol supplementationOther: dialysis techniquesOther: sunlight exposure time

Interventions

ergocalciferol supplementationOTHER

Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.

Also known as: nutritional vitamin D supplementation
Vitamin D supplementation using fixed dose regimenVitamin D supplementation using titration regimen
dialysis techniquesOTHER

Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.

Also known as: mode of dialysis
Vitamin D supplementation using fixed dose regimenVitamin D supplementation using titration regimen
sunlight exposure timeOTHER

Both groups will be advised to receive similar hours of daily sunlight exposure time.

Vitamin D supplementation using fixed dose regimenVitamin D supplementation using titration regimen

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • on maintenance dialysis (hemodialysis or peritoneal dialysis) \> 3 months
  • (OH)D \< 30 ng/ml
  • able to provide inform consent form

You may not qualify if:

  • current ergocalciferol or cholecalciferol treatment
  • known allergy to ergocalciferol
  • active inflammation or infection
  • advanced stage of cancer
  • pregnancy
  • lactation
  • on immunosuppressive drugs or corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn Univeristy

Bangkok, Thailand

Location

MeSH Terms

Conditions

Vitamin D DeficiencyKidney Failure, Chronic

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Piyawan Kittiskulnam

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 28, 2022

Study Start

August 1, 2022

Primary Completion

May 31, 2023

Study Completion

December 31, 2023

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)